The Efficacy and Safety of FE 200486 in Treatment of Patients Suffering From Prostate Cancer

What Was Tested

In this phase 2 trial, researchers set out to test Degarelix.

It had three arms (groups): Degarelix 80/80 + 40 (experimental), Degarelix 40/40 + 40 (experimental) and Degarelix 80 + 20 (experimental).

The registry classes the interventions as drug.

More on the Plan

Degarelix was not FDA regulated at the time of the trial.

After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.

Who Took Part

129 actual participants took part.

It was open to men only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Signed informed consent before any trial related activity. Proven prostate cancer with a need for endocrine treatment. Testosterone level within the normal range for the age.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: previous or current hormonal treatment of prostate cancer; candidate for prostatectomy or radiotherapy; history of severe asthma, anaphylactic reactions or quincke's oedema.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Degarelix group and the comparison group should start out alike.

The Degarelix group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Degarelix study: the participants and staff both knew the treatment.

It started in 2001-03 with completion listed for 2002-05.

It ran at 16 sites in United Kingdom (16).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Participants With Testosterone <0.5 Nanogram/Milliliter (time frame: Weeks 1,2,4,8,12,16,20,24).

It also tracked 6 secondary outcomes, for example Number of Participants With Testosterone < 0.5 Nanogram/Milliliter at All Visits Between Weeks 4-24, Number of Participants Not Meeting a Testosterone Withdrawal Criterion Between Weeks 4-24, Number of Participants Who Met the Withdrawl Criteria for Prostate-specific Antigen, Number of Participants With Normal Prostate-specific Antigen Levels During the Study, The Number of Participants With Abnormal Liver Function Tests and Percentage Change in Vital Signs and Body Weight.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Degarelix in 129 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Degarelix compound page, all human trials.